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An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Etanercept
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Device, Auto-injector, SureClick, Enbrel, Etanercept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Diagnosis of rheumatoid arthritis RA subjects 18 years or older Currently taking etanercept in pre-filled syringes for at least 4 weeks Subjects must give written informed consent Subjects must be able to read and write in English Exclusion Criteria: - Subject is not using adequate contraception Subject is pregnant or breast feeding Significant concurrent medical diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Single-Arm

    Arm Description

    Open-lable Single Arm Study

    Outcomes

    Primary Outcome Measures

    To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.

    Secondary Outcome Measures

    To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects.
    To determine the rate of failed drug deliveries (as opposed to device failures).

    Full Information

    First Posted
    June 27, 2006
    Last Updated
    January 17, 2020
    Sponsor
    Amgen
    Collaborators
    Immunex Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00346294
    Brief Title
    An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis
    Official Title
    An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen
    Collaborators
    Immunex Corporation

    4. Oversight

    5. Study Description

    Brief Summary
    An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    Rheumatoid Arthritis, Device, Auto-injector, SureClick, Enbrel, Etanercept

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    115 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single-Arm
    Arm Type
    Other
    Arm Description
    Open-lable Single Arm Study
    Intervention Type
    Drug
    Intervention Name(s)
    Etanercept
    Intervention Description
    Intervention type was to study the drug delivery method.
    Primary Outcome Measure Information:
    Title
    To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.
    Time Frame
    22 Days
    Secondary Outcome Measure Information:
    Title
    To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects.
    Time Frame
    22 Days
    Title
    To determine the rate of failed drug deliveries (as opposed to device failures).
    Time Frame
    22 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Diagnosis of rheumatoid arthritis RA subjects 18 years or older Currently taking etanercept in pre-filled syringes for at least 4 weeks Subjects must give written informed consent Subjects must be able to read and write in English Exclusion Criteria: - Subject is not using adequate contraception Subject is pregnant or breast feeding Significant concurrent medical diseases
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.enbrel.com/
    Description
    FDA-approved Drug Labeling
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis

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